SAFETY DATA SHEET. Version: 3.0

Transcription

1 Page 1 of 7 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKING Product Identifier Trade Name: Chemical Family: Caverject;Caverject Impulse; Caverject Dual; Alproject Mixture Relevant Identified Uses of the Substance or Mixture and Uses Advised Against Intended Use: Pharmaceutical product for the treatment of male erectile dysfunction Details of the Supplier of the Safety Data Sheet Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York Emergency telephone number: CHEMTREC (24 hours): Contact pfizer-msds@pfizer.com Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom (0) Emergency telephone number: International CHEMTREC (24 hours): HAZARDS IDENTIFICATION Classification of the Substance or Mixture GHS - Classification Not classified as hazardous US OSHA Specific - Classification Physical Hazard: Combustible Dust EU Classification: EU Indication of danger: Not classified Label Elements Signal Word: Hazard Statements: Warning May form combustible dust concentrations in air Other Hazards Australian Hazard Classification (NOHSC): Note: Non-Hazardous Substance. Non-Dangerous Goods. This document has been prepared in accordance with standards for workplace safety, which requires the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warning included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.

2 Page 2 of 7 3. COMPOSITION / INFORMATION ON INGREDIENTS Hazardous Ingredient CAS Number EU EINECS/ELINCS List EU Classification GHS Classification Xn;R22 Acute Tox. 3 (H301) % Ingredient CAS Number EU EINECS/ELINCS List EU Classification GHS Classification Sodium citrate, dihydrate * Lactose * % Additional Information: * Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. In accordance with 29 CFR , the exact percentage composition of this mixture has been withheld as a trade secret. For the full text of the R phrases and CLP/GHS abbreviations mentioned in this Section, see Section FIRST AID MEASURES Description of First Aid Measures Eye Contact: Skin Contact: Ingestion: Inhalation: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention immediately. Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention. Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately. Remove to fresh air and keep patient at rest. Seek medical attention immediately. Most Important Symptoms and Effects, Both Acute and Delayed Symptoms and Effects of For information on potential signs and symptoms of exposure, See Section 2 - Hazards Exposure: Identification and/or Section 11 - Toxicological Information. Medical Conditions None known Aggravated by Exposure: Indication of the Immediate Medical Attention and Special Treatment Needed Notes to Physician: None 5. FIRE FIGHTING MEASURES Extinguishing Media: Extinguish fires with CO2, extinguishing powder, foam, or water. Special Hazards Arising from the Substance or Mixture Hazardous Combustion Carbon dioxide, carbon monoxide Products: Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.

3 Page 3 of 7 Advice for Fire-Fighters During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus. 6. ACCIDENTAL RELEASE MEASURES Personal Precautions, Protective Equipment and Emergency Procedures Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure. Environmental Precautions Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release. Methods and Material for Containment and Cleaning Up Measures for Cleaning / Contain the source of spill if it is safe to do so. Collect spilled material by a method that Collecting: controls dust generation. A damp cloth or a filtered vacuum should be used to clean spills of dry solids. Clean spill area thoroughly. Additional Consideration for Large Spills: Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel. 7. HANDLING AND STORAGE Precautions for Safe Handling Avoid generating airborne dust. Avoid breathing dust. Avoid contact with eyes, skin and clothing. When handling, use appropriate personal protective equipment (see Section 8). Wash thoroughly after handling. Releases to the environment should be avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potential points of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA filtration systems or other equivalent controls. Conditions for Safe Storage, Including any Incompatibilities Storage Conditions: Store as directed by product packaging. Specific end use(s): Pharmaceutical drug product 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Control Parameters Pfizer OEL TWA-8 Hr: 0.5 µg/m 3 Analytical Method: Exposure Controls Engineering Controls: Personal Protective Equipment: Hands: Eyes: Skin: Respiratory protection: Analytical method available for. Contact Pfizer Inc for further information. Engineering controls should be used as the primary means to control exposures. General room ventilation is adequate unless the process generates dust, mist or fumes. Keep airborne contamination levels below the exposure limits listed above in this section. Refer to applicable national standards and regulations in the selection and use of personal protective equipment (PPE). Impervious gloves are recommended if skin contact with drug product is possible and for bulk processing operations. Wear safety glasses or goggles if eye contact is possible. Impervious protective clothing is recommended if skin contact with drug product is possible and for bulk processing operations. If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL.

4 Page 4 of 7 9. PHYSICAL AND CHEMICAL PROPERTIES Physical State: Odor: Molecular Formula: Powder. Mixture Color: Odor Threshold: Molecular Weight: White. Mixture Solvent Solubility: Water Solubility: Solubility: Soluble: Water ph:. Melting/Freezing Point ( C): Boiling Point ( C):. Partition Coefficient: (Method, ph, Endpoint, Value) Predicted 7.4 Log D Sodium citrate, dihydrate Lactose Decomposition Temperature ( C):. Evaporation Rate (Gram/s): Vapor Pressure (kpa): Vapor Density (g/ml): Relative Density: Viscosity: Flammablity: Autoignition Temperature (Solid) ( C): Flammability (Solids): Flash Point (Liquid) ( C): Upper Explosive Limits (Liquid) (% by Vol.): Lower Explosive Limits (Liquid) (% by Vol.): 10. STABILITY AND REACTIVITY Reactivity: Chemical Stability: Possibility of Hazardous Reactions Oxidizing Properties: Conditions to Avoid: Incompatible Materials: Hazardous Decomposition Products: Stable under normal conditions of use. Fine particles (such as dust and mists) may fuel fires/explosions. As a precautionary measure, keep away from strong oxidizers 11. TOXICOLOGICAL INFORMATION Information on Toxicological Effects General Information: Long Term: The information included in this section describes the potential hazards of the individual ingredients. Repeat-dose studies in animals have shown a potential to cause adverse effects on reproductive system, the developing fetus.

5 Page 5 of TOXICOLOGICAL INFORMATION Known Clinical Effects: Clinical use of this drug has caused symptoms of asthma, vomiting, diarrhea, increased bleeding time, clotting abnormalities, flushing, decrease in blood pressure (hypotension), decreased heart rate (bradycardia). Stimulates smooth muscle contraction. Acute Toxicity: (Species, Route, End Point, Dose) Rat Oral LD mg/kg Rat Para-periosteal LD mg/kg Rat Intraperitoneal LD mg/kg Mouse Oral LD mg/kg Mouse Intravenous LD 50 21mg/kg Acute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable at the highest dose used in the test. Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s)) Not specified Rat Oral1 mg/kg/day Maternal toxicity, Reproductive toxicity Genetic Toxicity: (Study Type, Cell Type/Organism, Result) Bacterial Mutagenicity (Ames) Salmonella Negative Unscheduled DNA Synthesis Negative Mammalian Cell Mutagenicity HGPRT Negative Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA. 12. ECOLOGICAL INFORMATION Environmental Overview: Toxicity: Persistence and Degradability: Environmental properties have not been investigated. Releases to the environment should be avoided. Bio-accumulative Potential: Partition Coefficient: (Method, ph, Endpoint, Value) Predicted 7.4 Log D Mobility in Soil:

6 Page 6 of DISPOSAL CONSIDERATIONS Waste Treatment Methods: Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered. Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques for waste and wastewater. 14. TRANSPORT INFORMATION The following refers to all modes of transportation unless specified below. Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. 15. REGULATORY INFORMATION Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture Canada - WHMIS: Classifications WHMIS hazard class: None required This product has been classified in accordance with the hazard criteria of the CPR and the MSDS contains all of the information required by the CPR. Sodium citrate, dihydrate CERCLA/SARA 313 Emission reporting California Proposition 65 Australia (AICS): EU EINECS/ELINCS List Lactose CERCLA/SARA 313 Emission reporting California Proposition 65 Inventory - United States TSCA - Sect. 8(b) Australia (AICS): REACH - Annex IV - Exemptions from the obligations of Register: EU EINECS/ELINCS List CERCLA/SARA 313 Emission reporting California Proposition 65

7 Page 7 of REGULATORY INFORMATION Standard for the Uniform Scheduling Schedule 4 for Drugs and Poisons: EU EINECS/ELINCS List OTHER INFORMATION Text of R phrases and GHS Classification abbreviations mentioned in Section 3 Acute toxicity, oral-cat.3; H301 - Toxic if swallowed Xn - Harmful R22 - Harmful if swallowed. Data Sources: Reasons for Revision: Revision date: Prepared by: Pfizer proprietary drug development information. Publicly available toxicity information. Updated Section 7 - Handling and Storage. Updated Section 2 - Hazard Identification. Updated Section 3 - Composition / Information on Ingredients. Updated Section 11 - Toxicology Information. Updated Section 12 - Ecological Information. Updated Section 16 - Other Information. 07-Mar-2015 Product Stewardship Hazard Communication Pfizer Global Environment, Health, and Safety Operations Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known information at this time. End of Safety Data Sheet